The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Topaz Ez Microdebrider Coblation Wand With Integrated Finger Switch.
| Device ID | K140521 |
| 510k Number | K140521 |
| Device Name: | TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCH |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ARTHROCARE CORPORATION 7000 W William Cannon Dr Austin, TX 78735 |
| Contact | Mitchell A Dhority |
| Correspondent | Mitchell A Dhority ARTHROCARE CORPORATION 7000 W William Cannon Dr Austin, TX 78735 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-04 |
| Decision Date | 2014-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817470003574 | K140521 | 000 |
| 00885556724705 | K140521 | 000 |